EP2506898A1 - Dispositif d'administration de médicament et emballage associé - Google Patents

Dispositif d'administration de médicament et emballage associé

Info

Publication number
EP2506898A1
EP2506898A1 EP10784803A EP10784803A EP2506898A1 EP 2506898 A1 EP2506898 A1 EP 2506898A1 EP 10784803 A EP10784803 A EP 10784803A EP 10784803 A EP10784803 A EP 10784803A EP 2506898 A1 EP2506898 A1 EP 2506898A1
Authority
EP
European Patent Office
Prior art keywords
drug delivery
delivery device
protective cover
cartridge
ambient temperature
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
EP10784803A
Other languages
German (de)
English (en)
Other versions
EP2506898B1 (fr
Inventor
Christian Pommerau
Anke Liewald
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Sanofi Aventis Deutschland GmbH
Original Assignee
Sanofi Aventis Deutschland GmbH
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Sanofi Aventis Deutschland GmbH filed Critical Sanofi Aventis Deutschland GmbH
Priority to EP10784803.8A priority Critical patent/EP2506898B1/fr
Publication of EP2506898A1 publication Critical patent/EP2506898A1/fr
Application granted granted Critical
Publication of EP2506898B1 publication Critical patent/EP2506898B1/fr
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/06—Ampoules or carpules
    • A61J1/062—Carpules
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31533—Dosing mechanisms, i.e. setting a dose
    • A61M5/31545—Setting modes for dosing
    • A61M5/31548—Mechanically operated dose setting member
    • A61M5/3155—Mechanically operated dose setting member by rotational movement of dose setting member, e.g. during setting or filling of a syringe
    • A61M5/31551—Mechanically operated dose setting member by rotational movement of dose setting member, e.g. during setting or filling of a syringe including axial movement of dose setting member
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31565—Administration mechanisms, i.e. constructional features, modes of administering a dose
    • A61M5/31576—Constructional features or modes of drive mechanisms for piston rods
    • A61M5/31583—Constructional features or modes of drive mechanisms for piston rods based on rotational translation, i.e. movement of piston rod is caused by relative rotation between the user activated actuator and the piston rod
    • A61M5/31585—Constructional features or modes of drive mechanisms for piston rods based on rotational translation, i.e. movement of piston rod is caused by relative rotation between the user activated actuator and the piston rod performed by axially moving actuator, e.g. an injection button
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J2200/00—General characteristics or adaptations
    • A61J2200/70—Device provided with specific sensor or indicating means
    • A61J2200/72—Device provided with specific sensor or indicating means for temperature
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J2205/00—General identification or selection means
    • A61J2205/20—Colour codes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M2005/3125—Details specific display means, e.g. to indicate dose setting
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M2005/3125—Details specific display means, e.g. to indicate dose setting
    • A61M2005/3126—Specific display means related to dosing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/02—General characteristics of the apparatus characterised by a particular materials
    • A61M2205/0238—General characteristics of the apparatus characterised by a particular materials the material being a coating or protective layer
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/27—General characteristics of the apparatus preventing use
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3368—Temperature
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/583—Means for facilitating use, e.g. by people with impaired vision by visual feedback
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/583—Means for facilitating use, e.g. by people with impaired vision by visual feedback
    • A61M2205/584—Means for facilitating use, e.g. by people with impaired vision by visual feedback having a color code
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2209/00—Ancillary equipment
    • A61M2209/06—Packaging for specific medical equipment

Definitions

  • the present invention relates to drug delivery devices such as pen-type injectors, which allow administering a single or a number of pre-set doses of a medicinal product.
  • the invention relates to such drug delivery devices that are designed and configured for self-administration, hence to be directly handled by a patient.
  • Drug delivery devices allowing for multiple dosing of a required dosage of a liquid medicinal product, such as l iquid drugs, and further providing administration of the liquid to a patient, are as such well-known in the art. Generally, such devices have substantially the same purpose as that of an ordinary syringe.
  • Pen-type injectors of this kind have to meet a number of user specific
  • Some medicinal products for instance insulin, heparin or growth hormones have to be stored in a refrigerated environment in order to prevent disintegration or decomposition .
  • Some medicinal products that are typically subject to self- administration may even rapidly decompose when exposed to ambient
  • the user may play down the potential harmful effect of improperly stored drugs and/or devices.
  • the user or patient may be exposed to a considerable risk to health, once a drug delivery device and/or a cartridge containing a respective medicinal product has been improperly stored or otherwise improperly treated .
  • components such as packaging and/or cartridges providing the medicinal product.
  • the present invention provides a drug del ivery device for dispensing of a dose of a medicinal product.
  • the drug del ivery device is preferably designed as a pen-type injector providing injection and administration of a single or of multiple pre-set doses of a medicinal product.
  • the drug delivery device comprises at least a housing component and a drive mechanism, wherein the drive mechanism comprises an axially displaceable piston rod.
  • the piston rod is adapted to act on a piston of a cartridge to be inserted into the drug delivery device.
  • the cartridge can be removably arranged in a cartridge holder of the drug del ivery device.
  • the cartridge contains the medicinal product to be dispensed and further comprises a piston slidably disposed therein .
  • the cartridge is typically designed as a carpule or vial . It may also be configured as an ampoule or syringe.
  • the axially displaceable piston rod of the drive mechanism is adapted to apply distally directed thrust to the piston in order to expel a pre-defined amount of the medicinal product during a dose dispensing procedure.
  • the drug del ivery device is further provided with an protective cover serving as an indicator means and which is adapted to irreversibly change at least one of its visually perceptible properties in response to the ambient temperature rising above and/or dropping below at least one given predefined threshold, which is typically defined by the type and composition of the medicinal product.
  • the protective cover increases its degree of opacity and decreases its degree of transparency in response of the ambient temperature crossing the predefined threshold.
  • the protective and temperature sensitive cover is arranged across a functional component of the drug del ivery device that visually provides information about the device status and/or about the cartridge.
  • a functional component is either a part of the drive mechanism and/or may display device specific information to the end user.
  • the functional component may comprise a dose selecting window and/or may comprise a window embedded in a cartridge holder section of the drug delivery device, thereby providing visual access to a scale d isposed on a cartridge arranged therein.
  • the drug del ivery device turns itself inoperable as soon as the ambient temperature reaches a level which is non-suitable for the medicinal product stored therein.
  • an effective labelling of the drug delivery device can be provided indicating to the end user, that the device and/or the medicinal product contained therein should no longer be used.
  • the protective cover according to the present invention is indicative that the medicinal product and/or the drug delivery device has or have been subject to an inadmissible temperature, at which the medicinal product may have partially decomposed .
  • the at least one protective cover may be adapted to exclusively respond to a rise in temperature above a predefined upper threshold. Additionally, another or the same protective cover may accordingly be adapted to visually respond to a dropping of the ambient temperature beneath a lower threshold, which may for instance be characterized by a temperature, at which the chemical or physical consistency of the medicinal product does not allow for proper administration, hence injection of the medicinal product.
  • the protective cover irreversibly changes its colour in response to the ambient temperature crossing the at least one temperature threshold.
  • the indicator means may change from an initial colour to a first colour, e.g. when the ambient temperature rises above an upper threshold .
  • the protective cover may feature a different, second colour when the ambient temperature drops below a lower threshold. Said changes in colour are typically accompanied with a respective change in transparency and/or opacity. In this way, an end user can even be informed about the type of threshold, the ambient temperature has crossed.
  • temperature thresholds can for instance be implemented by making use of a plurality of protective covers being configured respectively.
  • a visible component of the drug delivery device is a component being visible by the end user in any conceivable configuration of the device. If, for instance, the protective cover is implemented in a housing component of the drug delivery device and if said component is configured substantially transparent, rising or falling of the ambient temperature across the at least one threshold may lead to a substantial change, typically to an increase in opacity of said housing component.
  • said housing component can irreversibly change its degree of transparency and may thus cover or hide relevant information required to operate the drug del ivery device. In this way, further use of the drug delivery device can almost entirely be prevented as soon as the ambient temperature has at least once traversed a given temperature threshold .
  • the protective cover is configured as a coating or as a label attached to an outer surface of the drug del ivery device or to components thereof.
  • the protective cover may be universally applied to any suitable device component, such as a main housing component, a cartridge holder or even to a removable cap of the device, e.g . in form of a coating or by way of an adhesive label .
  • a temperature- sensitive coating or a respective adhesive label may also be beneficial for a production and assembly process of such drug delivery devices.
  • Coatings or labels may be applied to a drug delivery device after its assembly has been completed .
  • temperature-sensitive labelling of a drug delivery device may be conducted after termination of an assembly procedure, which itself is therefore generally not affected by the temperature sensitive labelling .
  • the protective cover comprises at least one thermochromic additive.
  • thermochromic additives can be provided for instance in form of thermochromic pigments, microencapsulated particles and/or by way of nanoparticles having a geometric size in the molecular range.
  • Thermochromic pigments can for instance be applied in form of a coating, by way of an adhesive label and/or in form of an additive embedded in the bulk of a component of the drug del ivery device.
  • the thermochromic additive may further be mixed with other colour pigments allowing to modify the appearance of a respective device component according to given design requirements.
  • the protective cover is visibly embedded in or is attached to a dose indicating unit, a cartridge holder, a removable cap, a dose dial button, a dose inject button and/or a dial grip of the drug del ivery device.
  • Said components, typically visibly disposed to the user are particularly suitable to indicate, that the device and/or the medicinal product contained therein should no longer be used.
  • a replaceable needle assembly to be interconnected with the cartridge holder can be provided with the above described temperature-sensitive protective cover.
  • the protective cover is arranged at least across a dose displaying window.
  • the dose displaying window and the protective cover which is initially substantially transparent, allow a user to control the size of a set dose.
  • thermochromic additives for instance into the protective cover, its degree of transparency may drastically decrease and said protective cover may become entirely opaque when the ambient temperature crosses the at least one pre-defined threshold .
  • the opacity-increased protective cover hinders an end user in reading relevant dose information, which is required for dispending of a pre-defined dose.
  • the entire device substantially becomes unusable.
  • the protective cover becomes substantially opaque and/or non-transparent, once the ambient temperature traverses the predefined threshold.
  • the drug delivery device comprises a cartridge filled with the medicinal product.
  • the drug del ivery device may be designed as a disposable device and may be readily equipped with a filled cartridge. Instead of replacing an empty cartridge, the device itself can be discarded .
  • the invention further relates to a packaging for a drug delivery device, wherein the packaging comprises an indicator means or a protective cover adapted to irreversibly change at least one of its visually perceptible properties in response to the ambient temperature rising above and/or dropping below at least one pre-defined temperature threshold .
  • a packaging adapted to protect such drug del ivery devices or components thereof can be equipped with a temperature sensitive indicator means.
  • the packaging may comprise a package made of paper or cardboard .
  • the protective cover or indicator means on the packaging, an end user may even be informed of improper storage of such a drug delivery device even before unwrapping or opening said packaging.
  • an indicator means helps to detect weak points in a cold chain e.g. required for transportation of the device from the manufacturer to patients or to end consumers.
  • the packaging may be configured as an at least partially transparent packaging film or foil, in which the drug delivery device is for instance shrink-wrapped .
  • Such packaging film or packaging foil may also change its degree of opacity and/or its degree of transparency when exposed to an ambient temperature lying outside the predefined and ad missible temperature range.
  • a coating comprising thermochromic pigments and/or additional colour pigments.
  • the invention further relates to a cartridge to be used with a drug delivery device.
  • the cartridge wall comprises a temperature sensitive indicator means provided with a protective cover or with a respective coating adapted to irreversibly change increase its degree of
  • the cartridge wall e.g. made of glass
  • the cartridge wall may be coated with a thermochromic additive, irreversibly changing its colour and/or transparency such that for instance a scale disposed underneath is no longer readable when the ambient temperature rises above or falls below a predefined threshold.
  • transparency-changing additive can be embedded in the bulk of the material forming the cartridge wall .
  • the cartridge becomes non-usable if once exposed to unsuitable thermal conditions.
  • the invention can be universally applied not only to disposable but also to reusable drug delivery devices, wherein cartridges filled with the medicinal product to be dispensed can after usage be replaced by a new cartridge. Providing such replaceable cartridges with a temperature sensitive indicator means is beneficial for a surveillance of compl iances in a cold logistic chain of such cartridges.
  • the temperature sensitive protective cover is not only to be used with drug del ivery devices such like pen-type injectors but also with inhalers or the like devices.
  • ..medicament or “medicinal product”, as used herein, means a pharmaceutical formulation containing at least one pharmaceutically active compound, wherein in one embodiment the pharmaceutically active compound has a molecular weight up to 1500 Da and/or is a peptide, a proteine, a polysaccharide, a vaccine, a DNA, a RNA, a antibody, an enzyme, an antibody, a hormone or an oligonucleotide, or a mixture of the above-mentioned pharmaceutically active compound, wherein in a further embodiment the pharmaceutically active compound is useful for the treatment and/or prophylaxis of diabetes mellitus or complications associated with diabetes mellitus such as diabetic retinopathy, thromboembolism disorders such as deep vein or pulmonary thromboembolism, acute coronary syndrome (ACS), angina, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis and/or rheumatoid arthritis, wherein in in
  • Insulin analogues are for example Gly(A21 ), Arg(B31 ), Arg(B32) human insulin; Lys(B3), Glu(B29) human insulin; Lys(B28), Pro(B29) human insulin; Asp(B28) human insulin; human insulin, wherein proline in position B28 is replaced by Asp, Lys, Leu, Val or Ala and wherein in position B29 Lys may be replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.
  • Insulin derivates are for example B29-N-myristoyl-des(B30) human insulin; B29-N- palmitoyl-des(B30) human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin; B28-N-myristoyl LysB28ProB29 human insulin; B28-N-palmitoyl- LysB28ProB29 human insulin; B30-N-myristoyl-ThrB29LysB30 human insulin; B30-N- palmitoyl- ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-Y-glutamyl)-des(B30) human insulin; B29-N-(N-lithocholyl-Y-glutamyl)-des(B30) human insulin; ⁇ 29- ⁇ -( ⁇ - carboxyheptadecanoyl)-des(B30) human insulin and B29-N-(u)-carbox
  • Exendin-4 for example means Exendin-4(1 -39), a peptide of the sequence H-His-Gly-
  • Exendin-4 derivatives are for example selected from the following list of compounds:
  • H-(Lys)6-des Pro36, Pro37, Pro38 [Met(O)14, Asp28] Exendin-4(1 -39)-(Lys)6-NH2, H-Asn-(Glu)5 des Pro36, Pro37, Pro38 [Met(O)14, Asp28] Exendin-4(1 -39)-(Lys)6-NH2, H-Lys6-des Pro36 [Met(O)14, Trp(O2)25, Asp28] Exendin-4(1 -39)-Lys6-NH2,
  • Hormones are for example hypophysis hormones or hypothalamus hormones or regulatory active peptides and their antagonists as listed in Rote Liste, ed. 2008, Chapter 50, such as Gonadotropine (Follitropin, Lutropin, Choriongonadotropin, Menotropin), Somatropine (Somatropin), Desmopressin, Terlipressin, Gonadorelin, Triptorelin, Leuprorelin, Buserelin, Nafarelin, Goserelin.
  • Gonadotropine Follitropin, Lutropin, Choriongonadotropin, Menotropin
  • Somatropine Somatropin
  • Desmopressin Terlipressin
  • Gonadorelin Triptorelin
  • Leuprorelin Buserelin
  • Nafarelin Goserelin.
  • a polysaccharide is for example a glucosaminoglycane, a hyaluronic acid, a heparin, a low molecular weight heparin or an ultra low molecular weight heparin or a derivative thereof, or a sulphated, e.g. a poly-sulphated form of the above-mentioned polysaccharides, and/or a pharmaceutically acceptable salt thereof.
  • An example of a pharmaceutically acceptable salt of a poly-sulphated low molecular weight heparin is enoxaparin sodium.
  • Pharmaceutically acceptable salts are for example acid addition salts and basic salts.
  • Acid addition salts are e.g. HCI or HBr salts.
  • Basic salts are e.g. salts having a cation selected from alkali or alkaline, e.g. Na+, or K+, or Ca2+, or an ammonium ion N+(R1 )(R2)(R3)(R4), wherein R1 to R4 independently of each other mean: hydrogen, an optionally substituted C1 -C6-alkyl group, an optionally substituted C2-C6-alkenyl group, an optionally substituted C6-C10-aryl group, or an optionally substituted C6-C10- heteroaryl group.
  • Figure 1 shows a drug delivery device in cross section in an initial
  • Figure 2 illustrates the drug delivery device according to Figure 1 prior dose dispensing
  • Figure 3 shows another embodiment of a pen-type injector comprising a display window.
  • the drug del ivery device 4 as illustrated in Figures 1 and 2 comprises a cartridge holder 2 that serves to house and to receive a cartridge 8 filled with a medicinal product to be dispensed by the drive mechanism 1 0 of the drug delivery device 4.
  • the cartridge 8 comprises at its upper, hence proximal end section a piston 1 6 moveably disposed in said cartridge 8.
  • a removable cap 12 is releasably retained at a lower, distal end of the cartridge holder 2. In use, said cap 12 can be replaced by a suitable piercing element, such an injection needle, cannula or the like for dispensing and administering the liquid drug to a patient.
  • the entire cartridge holder 2 is further covered by another replaceable cap 14.
  • the outer dimensions of said replaceable cap 14 are similar or identical to the outer dimensions of a main housing component 1 5, which serves to accommodate the drive mechanism 10.
  • the drive mechanism 10 comprises a piston rod 18 having an outer thread 1 9 matching with an inner thread of an axially displaceable insert or lead screw 20. Moreover, the piston rod 18 is also threadedly engaged with an inner thread of an axially displaceable drive sleeve 22. Said piston rod 18 comprises a second threaded portion at its upper, proximal end section, which is not explicitly illustrated in the Figures. With its second threaded portion, it is threadedly engaged with the inner thread of the drive sleeve 22.
  • the piston rod 1 8 comprises a pressure piece 17 at its lower, hence distal, end section, which buts against a proximal end face of the piston 16 of the cartridge 8. In this way, distally directed thrust provided by the piston rod 1 8 is transferred to a respective distally directed movement of the piston 16, thereby expell ing a predefined amount of the liquid medicinal product contained in the cartridge 8.
  • first and second threads of the piston rod 18 are oppositely directed and comprise different leads.
  • an axial displacement of the drive sleeve 22 leads to a rotational movement of the piston rod, which due to the threaded engagement with the insert 20 becomes also subject to a respective axial displacement in distal direction, hence, towards the lower part of the drug del ivery device 4.
  • the drive mechanism 1 0 further comprises a dose dial sleeve 24 as well as a dose dial button 28, by means of which the drive mechanism 10 can be transferred into a configuration as illustrated in Figure 2, wherein the drive sleeve 22 and the dose dial sleeve 24 together with the dose dial button 28 and a dose button 26 axially protrude from the housing 1 5 of the drive mechanism 10.
  • a user may manually exert distally directed thrust to the dose button 26, which consequently leads to an axially and distally directed displacement of the entire drive mechanism 10. Due to the threaded engagement of the piston rod 1 8 with both, the drive sleeve 22 and the insert 20, distally directed movement of the piston rod 18 is reduced compared to the distally directed displacement of the drive sleeve 22.
  • any one or several of the illustrated parts and components of the drug del ivery device 4 according to Figures 1 and 2 that are visible to a user can be provided with a protective cover 30 according to the present invention.
  • the cover 30 is configured as a surface element arranged on the outer circumference of a cartridge holder 2.
  • the removable caps 12, 14, the main housing component 1 5, the dose dial button 28 as well as the dose inject button 26 can be provided with or can even be entirely configured as a protective cover being adapted to irreversibly change its degree of opacity and/or transparency in response to the ambient temperature rising above and/or dropping below at least one predefined threshold.
  • the cover or window 30 is arranged across a window section of the cartridge holder 2 and provides visual access to the cartridge 8 disposed therein.
  • the cartridge and in particular its scale serves as a functional component.
  • a dose dial sleeve 24 axially extending from the main housing component 1 5 as illustrated in Figure 2 can be regarded as functional component to be equipped with a temperature-sensitive protective cover providing a
  • the dose dial sleeve 24 is further provided with dose-related size information, a colour change or a change in opacity and/or in transparency may lead to a general unusability of the drug delivery device 4. If for instance a thermochromic coating covering a scale of the dose dial sleeve 24 becomes subject to a decrease in its degree of transparency, the scale providing important information for setting and/or dispensing of a dose will be no longer readable by the end user.
  • the protective cover is subject to a change in colour towards particular signal colours, such as red or comparable bright colours clearly indicating, that the drug delivery device and/or its medicinal product should no longer be used.
  • another drug delivery device 40 is illustrated.
  • This device 40 is also of pen-injector type. It comprises a main housing component 38 and a cartridge holder 42, adapted to hold a replaceable cartridge 8, which is filled with the medicinal product to be dispensed by the device 40. Also here, the cartridge holder 42 is covered by a replaceable cap 46. At the distal end portion of the cartridge holder 42, a needle assembly 45 protected by a needle cap 48 is further illustrated.
  • the main housing component 38 serves to house a drive mechanism, which is not further illustrated here. Further, the main housing component 38 comprises a through opening in form of a dose dial window 36. By rotating the dose dial 50, the rotating digits 34' and 34" will indicate the size of a dose being actually set and prepared for a subsequent dispensing procedure. After setting of a respective dose, by depressing of a dose inject button 52, the drive mechanism applies respective thrust to the piston of the cartridge 8 and a well-defined amount of the medicinal product can be administered.
  • the protective cover 32 is arranged across the window 36 of the main housing component 38.
  • the protective cover 32 is substantially transparent and allows reading of the dose- size related information as given by the digits 34', 34".
  • the protective cover 32 may change its colour and/or may change its degree of transparency and/or opacity, respectively. In this way, the user can be intuitively informed, that the device has been subject to an improper storage.

Abstract

La présente invention concerne un dispositif d'administration de médicament et en particulier un étiquetage sensible à la température de tels dispositifs. Le dispositif d'administration de médicament est conçu pour administrer une dose d'un médicament et comprend un logement (15; 38) et un mécanisme d'entraînement (10) comprenant une tige de piston déplaçable axialement (18) permettant d'agir sur un piston (16) d'une cartouche (18) contenant le médicament devant être administré. Le dispositif est en outre doté d'un moyen indicateur (30; 32) conçu pour modifier de manière irréversible au moins l'une de ses propriétés perceptibles visuellement en réponse à l'augmentation de la température ambiante au-dessus d'au moins un seuil prédéfini et/ou à la diminution de la température ambiante sous au moins un seuil prédéfini. Ledit moyen indicateur est de préférence conçu comme un couvercle de protection disposé sur une fenêtre de visualisation de dose du dispositif.
EP10784803.8A 2009-12-02 2010-12-01 Dispositif d'administration de médicaments et conditionnement correspondant Active EP2506898B1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP10784803.8A EP2506898B1 (fr) 2009-12-02 2010-12-01 Dispositif d'administration de médicaments et conditionnement correspondant

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP09177683 2009-12-02
EP10784803.8A EP2506898B1 (fr) 2009-12-02 2010-12-01 Dispositif d'administration de médicaments et conditionnement correspondant
PCT/EP2010/068593 WO2011067268A1 (fr) 2009-12-02 2010-12-01 Dispositif d'administration de médicament et emballage associé

Publications (2)

Publication Number Publication Date
EP2506898A1 true EP2506898A1 (fr) 2012-10-10
EP2506898B1 EP2506898B1 (fr) 2013-09-04

Family

ID=42236896

Family Applications (1)

Application Number Title Priority Date Filing Date
EP10784803.8A Active EP2506898B1 (fr) 2009-12-02 2010-12-01 Dispositif d'administration de médicaments et conditionnement correspondant

Country Status (6)

Country Link
US (2) US8968254B2 (fr)
EP (1) EP2506898B1 (fr)
JP (1) JP5755238B2 (fr)
CA (1) CA2779264A1 (fr)
DK (1) DK2506898T3 (fr)
WO (1) WO2011067268A1 (fr)

Families Citing this family (20)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ES2314182T3 (es) 2002-02-11 2009-03-16 Antares Pharma, Inc. Inyector intradermico.
EP1850892B2 (fr) 2005-01-24 2023-04-19 Antares Pharma, Inc. Injecteur a seringue preremplie assiste d'une aiguille
US9144648B2 (en) 2006-05-03 2015-09-29 Antares Pharma, Inc. Injector with adjustable dosing
WO2007131013A1 (fr) 2006-05-03 2007-11-15 Antares Pharma, Inc. Injecteur de reconstitution à deux étages
WO2009114542A1 (fr) 2008-03-10 2009-09-17 Antares Pharma, Inc. Dispositif de sécurité pour injecteur
EP2318075B1 (fr) 2008-08-05 2019-05-22 Antares Pharma, Inc. Injecteur à dosage multiple
EP2408493A1 (fr) 2009-03-20 2012-01-25 Antares Pharma, Inc. Système d'injection d'agents dangereux
GB2490721B (en) 2011-05-12 2017-03-01 Owen Mumford Ltd Injection devices
US9220660B2 (en) 2011-07-15 2015-12-29 Antares Pharma, Inc. Liquid-transfer adapter beveled spike
US8496619B2 (en) 2011-07-15 2013-07-30 Antares Pharma, Inc. Injection device with cammed ram assembly
PT2822618T (pt) 2012-03-06 2024-03-04 Antares Pharma Inc Seringa pré-cheia com característica de força de rutura
CN104427964A (zh) * 2012-04-03 2015-03-18 米迪缪尼有限公司 具有热变色应答指示剂的装置
JP6457383B2 (ja) 2012-04-06 2019-01-23 アンタレス・ファーマ・インコーポレーテッド テストステロン組成物の針支援式ジェット注入投与
WO2013169804A1 (fr) 2012-05-07 2013-11-14 Antares Pharma, Inc. Dispositif d'injection par jet assisté par une aiguille, présentant une force de déclenchement réduite
ES2763633T3 (es) 2013-02-11 2020-05-29 Antares Pharma Inc Dispositivo de inyección por chorro asistido por aguja que tiene fuerza de disparo reducida
ES2742046T3 (es) 2013-03-11 2020-02-12 Antares Pharma Inc Inyector de dosis con sistema de piñón
WO2014165136A1 (fr) 2013-03-12 2014-10-09 Antares Pharma, Inc. Seringues pré-remplies à volume constant et leurs trousses
JP7051293B2 (ja) 2013-10-24 2022-04-11 アムジエン・インコーポレーテツド 温度感知制御を伴う薬剤送達システム
WO2017207495A1 (fr) * 2016-05-30 2017-12-07 Novo Nordisk A/S Élément de montage pour dispositif accessoire
DE102018126140B4 (de) * 2018-10-22 2023-12-07 Voco Gmbh Vorrichtung mit einem thermochromen Temperaturindikator zur Aufnahme, Erwärmung und Applikation von Dentalmaterialien

Family Cites Families (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4179397A (en) * 1978-05-22 1979-12-18 American Can Company Indicator ink
FR2598225B1 (fr) * 1986-04-30 1988-08-26 Centre Nat Rech Scient Indicateurs de temperature a base de composes polydiacetyleniques
AU2001247721A1 (en) * 2000-03-23 2001-10-03 Antares Pharma, Inc. Single use disposable jet injector
SE516019C2 (sv) 2000-03-27 2001-11-12 Henry Norrby Förpackning för förvaring av varor i ett temperatursänkt preserverande tillstånd tillsammans med temperaturindikator för detta
US20050131355A1 (en) 2002-06-12 2005-06-16 Fritz Kirchhofer Injection or infusion device with refined surface
DE10226117A1 (de) * 2002-06-12 2004-01-08 Disetronic Licensing Ag Injektions- oder Infusionsvorrichtung mit Oberflächenveredelung
EP1642607A1 (fr) * 2004-10-04 2006-04-05 Sanofi-Aventis Deutschland GmbH Mécanisme d'affichage de dose destiné à un dispositif d'administration de médicament
EP2007341A1 (fr) 2006-04-20 2008-12-31 Ares Trading S.A. Procede de marquage destine a des articles pharmaceutiques
US20080085210A1 (en) 2006-10-05 2008-04-10 Henry Griesbach Decontamination of filtration media for respiration
JP2010515541A (ja) 2007-01-09 2010-05-13 ミスティック ファーマシューティカルズ， インコーポレイテッド 経鼻カートリッジデバイス
GB0710433D0 (en) * 2007-05-31 2007-07-11 Ucb Pharma Sa Auto-injector
DK2403562T3 (da) * 2009-03-05 2021-02-15 Sanofi Aventis Deutschland Lægemiddeladministrationsanordning, der viser brugsrelateret information

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See references of WO2011067268A1 *

Also Published As

Publication number Publication date
WO2011067268A1 (fr) 2011-06-09
US20150157798A1 (en) 2015-06-11
JP2013512703A (ja) 2013-04-18
JP5755238B2 (ja) 2015-07-29
CA2779264A1 (fr) 2011-06-09
EP2506898B1 (fr) 2013-09-04
US20130012884A1 (en) 2013-01-10
US8968254B2 (en) 2015-03-03
US9452262B2 (en) 2016-09-27
DK2506898T3 (da) 2013-12-09

Similar Documents

Publication Publication Date Title
US9452262B2 (en) Drug delivery device and associated packaging
AU2010255819B2 (en) Medicament identification system for multi-dose injection devices
EP2451507B1 (fr) Dispositif d'administration de médicaments avec indicateur mécanique ajustable par montage d'une cartouche
EP2488236B1 (fr) Ensemble support de cartouche pour dispositif d'administration de médicaments
US8784378B2 (en) Drug delivery device with light source
US20120253288A1 (en) Reminder device for drug delivery devices
CA2764048C (fr) Ensemble pour dispositif d'administration de medicament et dispositif d'administration de medicament
US20130345641A1 (en) Coding System for a Drug Delivery Device and Drug Delivery System
AU2011288404B2 (en) Differentiation for a drug delivery device
WO2011124631A1 (fr) Élément de raccordement de réservoir de médicament codé pourvu d'éléments de blocage pliables
EP2555818A2 (fr) Capuchon à code à utiliser avec un dispositif d'administration de médicament
EP2648785B1 (fr) Indicateur d'ouverture non autorisée pour un réservoir de médicament
WO2012010564A1 (fr) Cartouches de médicament ayant des dimensions non-standard
WO2012020091A1 (fr) Stylo injecteur avec collier rotatif muni d'éléments de codage

Legal Events

Date Code Title Description
PUAI Public reference made under article 153(3) epc to a published international application that has entered the european phase

Free format text: ORIGINAL CODE: 0009012

17P Request for examination filed

Effective date: 20120702

AK Designated contracting states

Kind code of ref document: A1

Designated state(s): AL AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LI LT LU LV MC MK MT NL NO PL PT RO RS SE SI SK SM TR

DAX Request for extension of the european patent (deleted)
GRAP Despatch of communication of intention to grant a patent

Free format text: ORIGINAL CODE: EPIDOSNIGR1

INTG Intention to grant announced

Effective date: 20130326

GRAS Grant fee paid

Free format text: ORIGINAL CODE: EPIDOSNIGR3

GRAA (expected) grant

Free format text: ORIGINAL CODE: 0009210

AK Designated contracting states

Kind code of ref document: B1

Designated state(s): AL AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LI LT LU LV MC MK MT NL NO PL PT RO RS SE SI SK SM TR

REG Reference to a national code

Ref country code: GB

Ref legal event code: FG4D

REG Reference to a national code

Ref country code: CH

Ref legal event code: EP

REG Reference to a national code

Ref country code: AT

Ref legal event code: REF

Ref document number: 630128

Country of ref document: AT

Kind code of ref document: T

Effective date: 20130915

REG Reference to a national code

Ref country code: IE

Ref legal event code: FG4D

REG Reference to a national code

Ref country code: DE

Ref legal event code: R096

Ref document number: 602010010100

Country of ref document: DE

Effective date: 20131031

REG Reference to a national code

Ref country code: DK

Ref legal event code: T3

Effective date: 20131202

REG Reference to a national code

Ref country code: AT

Ref legal event code: MK05

Ref document number: 630128

Country of ref document: AT

Kind code of ref document: T

Effective date: 20130904

REG Reference to a national code

Ref country code: NL

Ref legal event code: VDEP

Effective date: 20130904

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: LT

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20130904

Ref country code: SE

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20130904

Ref country code: CY

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20130918

Ref country code: NO

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20131204

Ref country code: AT

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20130904

Ref country code: HR

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20130904

REG Reference to a national code

Ref country code: NL

Ref legal event code: VDEP

Effective date: 20130904

REG Reference to a national code

Ref country code: LT

Ref legal event code: MG4D

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: FI

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20130904

Ref country code: GR

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20131205

Ref country code: LV

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20130904

Ref country code: SI

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20130904

Ref country code: PL

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20130904

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: CY

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20130904

Ref country code: BE

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20130904

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: EE

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20130904

Ref country code: RO

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20130904

Ref country code: CZ

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20130904

Ref country code: IS

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20140104

Ref country code: NL

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20130904

Ref country code: SK

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20130904

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: ES

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20130904

REG Reference to a national code

Ref country code: DE

Ref legal event code: R097

Ref document number: 602010010100

Country of ref document: DE

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: PT

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20140106

PLBE No opposition filed within time limit

Free format text: ORIGINAL CODE: 0009261

STAA Information on the status of an ep patent application or granted ep patent

Free format text: STATUS: NO OPPOSITION FILED WITHIN TIME LIMIT

26N No opposition filed

Effective date: 20140605

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: LU

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20131201

Ref country code: IT

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20130904

REG Reference to a national code

Ref country code: DE

Ref legal event code: R097

Ref document number: 602010010100

Country of ref document: DE

Effective date: 20140605

REG Reference to a national code

Ref country code: IE

Ref legal event code: MM4A

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: IE

Free format text: LAPSE BECAUSE OF NON-PAYMENT OF DUE FEES

Effective date: 20131201

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: MC

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20130904

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: SM

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20130904

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: MK

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20130904

Ref country code: RS

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20131204

Ref country code: HU

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT; INVALID AB INITIO

Effective date: 20101201

Ref country code: BG

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20130904

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: MT

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20130904

REG Reference to a national code

Ref country code: FR

Ref legal event code: PLFP

Year of fee payment: 6

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: TR

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20130904

REG Reference to a national code

Ref country code: FR

Ref legal event code: PLFP

Year of fee payment: 7

PGFP Annual fee paid to national office [announced via postgrant information from national office to epo]

Ref country code: CH

Payment date: 20161213

Year of fee payment: 7

Ref country code: DK

Payment date: 20161212

Year of fee payment: 7

REG Reference to a national code

Ref country code: FR

Ref legal event code: PLFP

Year of fee payment: 8

REG Reference to a national code

Ref country code: DK

Ref legal event code: EBP

Effective date: 20171231

REG Reference to a national code

Ref country code: CH

Ref legal event code: PL

REG Reference to a national code

Ref country code: FR

Ref legal event code: PLFP

Year of fee payment: 9

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: AL

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20130904

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: LI

Free format text: LAPSE BECAUSE OF NON-PAYMENT OF DUE FEES

Effective date: 20171231

Ref country code: CH

Free format text: LAPSE BECAUSE OF NON-PAYMENT OF DUE FEES

Effective date: 20171231

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: DK

Free format text: LAPSE BECAUSE OF NON-PAYMENT OF DUE FEES

Effective date: 20171231

PGFP Annual fee paid to national office [announced via postgrant information from national office to epo]

Ref country code: FR

Payment date: 20230929

Year of fee payment: 14

PGFP Annual fee paid to national office [announced via postgrant information from national office to epo]

Ref country code: GB

Payment date: 20231012

Year of fee payment: 14

PGFP Annual fee paid to national office [announced via postgrant information from national office to epo]

Ref country code: DE

Payment date: 20231003

Year of fee payment: 14